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A Randomized Controlled Trial of Doxycycline Post Exposure Prophylaxis to Prevent Incident Bacterial STIs Among Women in the United States

ConditionsChlamydia FemalesGonorrhea FemaleSyphilis FemaleAdherenceProphylaxisPrevention
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorTulane University

About this trial

The bacterial sexually transmitted infections (STIs) chlamydia, gonorrhea, and syphilis cause multiple adverse outcomes in women, and prevention strategies are critically needed. This project will determine the efficacy of doxycycline post-exposure prophylaxis (doxy PEP) to prevent STIs among women through a phase IV, open-label, randomized controlled trial.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female

Aged 18-35

diagnosis of CT, gonorrhea, syphilis, or trichomonas in the past year

reporting 2 or more sexual partners in the past 6 months

Disqualifiers

Pregnant, nursing, or intending to become pregnant

Reported allergy to tetracyclines

Liver disease or end-stage renal disease

Non-English Speaking

Trial design

Design model

Parallel

Treatments tested in this trial

  • Doxycycline

    Drug

    Enrolled participants will be randomized 2:1 to receive 200 mg of doxy PEP taken within 24 hours of condomless sex versus standard of care. Only one trial of the use of doxy PEP (dPEP Kenya) has been conducted among women, and unfortunately this study had a null result.

  • Standard of Care (SOC)

    Other intervention

    Enrolled participants will be randomized 2:1 to receive 200 mg of doxy PEP taken within 24 hours of condomless sex versus standard of care. Only one trial of the use of doxy PEP (dPEP Kenya) has been conducted among women, and unfortunately this study had a null result.

Treatment groups

519 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

chlamydia incidence

The primary outcome will be the number of CT infections over person-time (incidence rate).

Time frame
Participants will be evaluated at baseline and quarterly for 48 weeks with STI testing at each visit.

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tulane University

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

University of Alabama at Birmingham

Collaborator

Louisiana State University Health Sciences Center in New Orleans

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: